Clinical research is the scientific examination of medical treatments or devices, involving voluntary participation from individuals in clinical studies. The goal of clinical studies is to explore new methods for detecting, preventing, or treating disease by testing investigational medical treatments or devices in humans to assess their safety and efficacy. Clinical studies are essential for the development of new medications or medical devices. Without clinical studies, creating new safe and effective medical treatments is impossible. Clinical studies may aim to:

• Explore new treatments or combinations of treatments
• Compare new treatments with existing treatments
• Investigate new uses for existing treatments
• Examine new surgical methods

Clinical studies involve collaboration between researchers and participants to answer questions that cannot be addressed otherwise. People participate in clinical studies for various reasons. If you have a disease, you might want to:

• Help others, including future family members, who may be at risk of developing the same disease as you
• Receive regular monitoring, care, and attention from the research staff
• Gain more knowledge about your disease and health
• Try new treatments that may be more effective than existing ones Healthy volunteers may also join to help others and advance scientific knowledge. By volunteering in a clinical study, you contribute to medical research that could improve healthcare for future generations. Clinical studies may also offer alternative treatment options for people who don't respond well to current treatments, providing hope for many.

Clinical studies require a diverse group of participants. Some studies look for patients with specific conditions, while others seek healthy volunteers. Studies involving healthy volunteers aim to create new knowledge rather than provide direct benefits to participants. Healthy volunteers help set a baseline for "normal" that researchers can use to compare patient groups. They are often matched to patients based on factors like gender, age, or family relationship, and undergo the same tests, procedures, or treatments as the patient group. By comparing patient and healthy groups, researchers gain insights into the disease process.

The development of medical treatments is a lengthy process. After thorough laboratory testing, only the most promising treatments move into clinical studies. These treatments progress through different phases, where more information is gathered about their effectiveness and risks. Only if the results from clinical studies validate the treatment's safety and efficacy can it be approved for sale.

Sponsors of clinical studies may be individuals, institutions, companies, or other organizations that initiate, manage, or fund the study. Typically, they do not conduct the clinical studies themselves.

A clinical study protocol is a detailed plan that guides a clinical study. It is designed to balance the potential benefits and risks to participants while answering specific scientific questions. A protocol includes:

• The study's purpose
• Eligibility criteria for participants
• Details about tests, medical evaluations, procedures, and treatments
• Measures for protecting participants against risks
• The study's duration
• The type of data that will be collected

A physician, known as the principal investigator (PI), leads the study. The research team regularly monitors participants' health to assess the safety and efficacy of the medical treatment.

Clinical studies are conducted in four stages called phases, each with its own objectives and questions to address. All new medical treatments must be tested through these phases before approval:
Phase I: Researchers test a new treatment for the first time with a small group of people (20-80) to assess its safety and identify side effects.
Phase II: The treatment is given to a larger group of people (100-300) to determine its effectiveness and further evaluate its safety.
Phase III: A larger group (1,000-3,000) receives the treatment to confirm its effectiveness, monitor side effects, compare it with standard treatments, and gather information needed for approval.
Phase IV: After the treatment is approved and available for sale, researchers continue to track its safety in the general population and gather more information about its benefits and optimal use.

Researchers follow guidelines in the clinical study protocol to determine who can participate in a study. These guidelines are known as inclusion and exclusion criteria.
• Inclusion criteria specify the factors that qualify someone to take part in a study.
• Exclusion criteria list factors that disqualify someone from participating.
Criteria may include age, gender, disease type and stage, medical history, and other health conditions. Providing accurate information helps the research team decide whether you can safely join the study. Inclusion and exclusion criteria help identify suitable participants and protect their safety, ensuring reliable data collection. These criteria are not intended to personally reject anyone.

Informed consent is the process of learning about a study to help you decide whether to participate. During this process, you'll receive information about the study's purpose, duration, procedures, and potential risks and benefits.
If you agree to participate, you'll sign an informed consent form stating your understanding and agreement. This form is not a contract, and you can withdraw from the study at any time. Your decision to participate should be well-considered because the study's success depends on a certain percentage of participants completing the study. Early withdrawals could result in the study being canceled, impacting other participants and potentially delaying approval of a new treatment.

A placebo is an inactive product that looks like the experimental treatment but has no therapeutic effect. Comparing a new treatment with a placebo can quickly and reliably demonstrate the treatment's effectiveness and safety.
In "randomized, placebo-controlled" studies, participants are randomly assigned to either receive the experimental treatment or a placebo/standard care. Researchers compare outcomes from both groups to assess the treatment's impact. Typically, neither participants nor the research team know who receives which treatment, but medical necessity can reveal this information.

Health authorities and ethical committees (such as IRBs in the U.S.) must approve every study to ensure participants' safety. Research staff must follow strict rules to keep participants safe and protect their information. Safety measures include:
• Health authority approval of the clinical study protocol to ensure scientific relevance and minimize risks to participants.
• IRB approval of the protocol and related patient materials to ensure ethical standards.
• Data Protection Agency approval for sites to collect personal data from participants and maintain privacy.
• Informed consent to explain study details, including risks and potential benefits, before you decide to join.
• Right to withdraw allows you to leave the study at any time.

The duration of clinical studies varies from days to years. Some studies require minimal time and effort, while others may be more time-consuming. Studies often involve multiple visits to the research site. Travel expenses are often covered by the site. The informed consent process includes a detailed explanation of the study's procedures and requirements.

The research team's primary goal is to ensure participants' safety. All clinical studies carry some risk, and the team will discuss possible side effects or risks before you join a study. Participation may not guarantee direct benefits, and even promising experimental treatments may not cure the disease in question. If an experimental treatment falls short, it is valuable information for researchers.
In randomized, placebo-controlled studies, participants may not know whether they receive the experimental treatment or a placebo, and results may not be immediate. Communicating openly with research staff can clarify why studies are designed this way and what you can expect.

Once you've identified a clinical study you're interested in, you can contact the research site by filling out the contact form or call the clinic. Contact information is usually included in the study description. The steps are as follows:

1. Research staff explain the study and collect information about you.
2. If you agree to participate, you sign an informed consent form.
3. You're medically examined to ensure you qualify for the study.
4. If eligible, you schedule a first visit for physical tests.
5. Depending on the study type, you're randomly assigned to the test group (receiving the experimental treatment) or control group (receiving placebo).
6. Follow study procedures and report any issues or concerns to the researchers.
7. Attend scheduled visits for physical exams, evaluations, and discussions with the research staff. The team collects data on treatment effects and your safety.
8. Continue seeing your primary care provider for health issues unrelated to the study.